The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To update sections 4.2, 4.4 and 4.8 of the Intrapharm Zoledronic acid SmPC (Type IB MRP variation approved in Ireland 24Sep2015) to reflect the current knowledge on osteonecrosis of the jaw (ONJ) following CHMP opinion (in relation to Zometa). Consequently, the Intrapharm PIL (also approved by HPRA 24Sep2015) has been updated. Patient alert card (being) implemented as a consequence.

Updated on 1 October 2015 PIL

Reasons for updating

Change to warnings or special precautions for use

Change to side-effects

Change to date of revision

Updated on 21 May 2015 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 5.2 - Pharmacokinetic properties

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)